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510(k) K991001

MODIFICATION OF PROCATH ELECTROPHYSIOLOGY CATHETER, EP MEDSYSTEMS ELECTROPHYSIOLOGY CATHETER by Ep Medsystems — Product Code DRF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 1999
Date Received
March 25, 1999
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class
Class II
Regulation Number
870.1220
Review Panel
CV
Submission Type

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  • K063277 — MAPMATE (November 30, 2006)
  • K063113 — EP-WORKMATE (October 27, 2006)
  • K041442 — EP-4 CLINICAL STIMUTATOR (September 14, 2004)
  • K033963 — EP DEFLECTABLE CATHETERS (April 15, 2004)
  • K040207 — EP-4 CLINICAL STIMULATOR (February 27, 2004)
  • K031066 — VIEWMATE ULTRASOUND IMAGING SYSTEM (October 17, 2003)

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